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Appistry Begins Early Access for Cloud-based Genomic Test Ordering Service Ahead of Q2 Launch

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Appistry has soft-launched an early version of a new cloud-based genomic test ordering service that will target clinicians in community or regional hospitals who are interested in incorporating genomic testing into their practices but who may not have the domain knowledge necessary to access and use existing tests or the requisite infrastructure to develop their own.

Trevor Heritage, Appistry's vice president of corporate development and strategy, said that the company wants to test the service, called CloudDx, this quarter with a handful early access customers ahead of a formal launch planned for May at the American Society of Clinical Oncology meeting, where it will discuss the service in greater detail.

Specifically, Appistry is looking for clients that it can "work with interactively" to answer practical questions such as whether CloudDx's workflow satisfies hospitals' requirements and integrates with existing infrastructure such as electronic medical record systems as well as questions about potential legal, ethical, and reimbursement issues, he told BioInform "Basically, our goal this quarter is to get two or three customers … executing a dozen or so samples [on CloudDx] so that they can get a feeling for how this system works and how, within their hospital environment, they would capitalize on the capabilities that genomics-based testing offers."

CloudDx is designed to connect newcomers to genomics testing to hospitals, laboratories, and companies that offer these types tests and to supervise the logistics of getting their samples sequenced, analyzed, and interpreted. "Typically what we find is [that these] are hospitals that have that interest but they are limited due to the fact that their physicians don’t necessarily understand clinical genomics [or] don't have the budget nor the infrastructure to establish a sequencing and genomics workflow capability for themselves," Heritage explained. "Our CloudDx solution is basically that infrastructure for executing the test. So in a similar fashion to how a regional hospital might ask for a third-party facility to execute radiology tests for them, here they would just be going to a service that we are hosting for getting NGS genomics-based tests executed on their behalf."

Here's how the system will work: First, users select a specific test or tests they would like to run from a menu of options, which will include whole exome and panel-based tests for cancer, cardiology, respiratory diseases, pediatric disorders, and rare diseases, Heritage explained. Once they do so, the system will offer information on what samples the clinicians need to collect, in what quantity, and provide packaging and shipping information to send the samples to labs that will handle the sequencing. Appistry's system will also coordinate the analysis of the data from raw sequence through to clinical interpretation and deliver the final report back to the requesting physician. Throughout the process, the customer is kept abreast of the status of the sample and when they might expect to get their results back.

To build its testing menu, Appistry is planning to partner with teaching hospitals, medical schools, and commercial entities that have already developed genomics-based tests in the aforementioned areas. In selecting which tests to include in CloudDx, "our goal is to be broad in terms of the range of diseases that we can touch … but narrow in terms of the number of tests that we offer in each of those areas," Heritage said. This way, "[we don’t] confuse customer[s] by providing a large number of partially overlapping tests in the exact same disease area."

In most instances, the test providers will handle the data analysis and interpretation steps in addition to the sequencing themselves, but if one or more of these capabilities is lacking, Appistry will work with the lab or hospital in question to fill in the gaps, Heritage said. It has already tapped N-Of-One to handle clinical interpretation of data from oncology-based tests sold through CloudDx if it is not already offered by the test developer — both companies agreed to market and sell N-of-One's interpretation services and content alongside Appistry's next-generation sequencing analysis solutions and services earlier this year.

Appistry has begun reaching out to test providers and potential CloudDx customers — it will disclose who they are at later dates — and it is still accepting applications from potential testers. So far, Heritage said, the response from the company's target market has been "varied" but "extremely positive" with many seeing genomic testing as a service that could make them more attractive to prospective patients. Some of the community hospitals that Appistry has reached out to are located in the same geographical space as much larger hospital networks or academic teaching hospitals that have ready access to genomics testing and can offer patients more comprehensive treatment and care, giving them a competitive advantage over clinics that currently don't offer such services.

However, that interest comes coupled with some concern about "the reimbursement landscape and … [the] regulatory challenges that still exist within the space," Heritage said. "What we say to them is 'those are problems that we are going to try to tackle together … if you think about it, the teaching hospitals are successfully executing those tests on their patients, and they are finding ways to be reimbursed either partially or completely. So if you are a regional hospital that is interested in the space, why shouldn’t that be you?'"

When CloudDx comes to market later this year, Appistry will charge a fee per sample submitted for testing that will be decided on a test by test basis, Heritage said — the exact cost will depend on what sort of sample preparation and sequencing are needed for testing as well as the complexity of the analysis and interpretation.

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